Primary Sjögren Syndrome
Conditions
Brief summary
The goal of this clinical study is to learn if RSLV-132 improves the symptoms of SS in adults. It will also learn about the safety of RSLV-132. The main questions it aims to answer are: * Does RSLV-132 improve the cardinal symptoms of Sjogren's including fatigue, dryness and pain? * Does RSLV-132 improve the tiredness/fatigue caused by Sjogren's? * What are the blood levels of RSLV-132 over time? * What is the immune (antibody) response in the body to RSLV-132? * What is the safety profile of RSLV-132? Researchers will compare RSLV-132 to a placebo (a look-alike substance that contains no drug) to see if RSLV-132 improves the symptoms of pSS. Participants will: Take RSLV-132 or a placebo 13 times over 22 weeks Visit the clinic once every week for the first 2 weeks, then every 2 weeks until the end of treatment and then for a final time 4 weeks later (Day 211) for check-ups, tests and to answer questionnaires about their symptoms Record their symptoms every day on an electronic device
Interventions
DRUGRSLV-132
Fc fusion protein comprised of catalytically active human ribonuclease (RNase) fused to human immunoglobulin G1 (IgG1)
DRUGPlacebo
0.9% sodium chloride solution
Sponsors
Resolve Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Providing written informed consent * Weight at least 45 kg * Meet the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria for pSS * Diagnosis in the last 30 years * Positive anti-Ro/SSA antibody test * Score of 5 or higher on the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) scale and the ESSPRI fatigue scale * Of non childbearing potential or of childbearing potential and using highly effective contraceptive measures
Exclusion criteria
* Diagnosis of any active autoimmune disease other than pSS that could affect the efficacy assessments * Uncontrolled hypothyroidism or severe fibromyalgia * New medications or change in medications in the last 4 weeks for pSS symptoms * Receipt of other prohibited medications * Apheresis or blood donation * Allergic reaction to RSLV-132 or biologic therapy * Clinically significant infection in last 30 days * Participation in another clinical study * Malignancy in last 5 years * Positive test for HIV or hepatitis * Major surgery in last 30 days or anticipated surgery during the study * Pregnancy or breast feeding * Laboratory blood tests outside of specified ranges * Other medical conditions or medications that would make the participant unsuitable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of cardinal symptoms of Sjogren's | Measured daily from at least 7 days prior to first dose until 169 days after the first dose | Change from baseline in Sjogren's symptoms on Day 169 assessed using the Sjogren's Symptom Activity Patient Reported Outcome (SSA-PRO) instrument |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tiredness/fatigue assessment | Measured from before the first dose until Day 169 | Change from baseline in the Patient Reported Outcomes Measurement Information System Fatigue Short Form 10a (PROMIS SF10a) on Day 169 |
| RSLV-132 pharmacokinetics | Measured from before the first dose until Day 211 | Serum concentrations of RSLV-132 using an assay measuring RNAse enzyme activity |
| RSLV-132 immunogenicity | Measured from before the first dose until Day 211 | Presence of antibodies to RSLV-132 measured using an immunoassay |
| Adverse events | From the first dose of Investigational Product until Day 211 | Incidence of serious and non-serious adverse events |
Countries
United States
Contacts
Primary ContactPatientWing https://app.patientwing.com/campaign/clinicaltrials.gov
Outcome results
None listed